Endotoxins Schmendotoxins!

The shocking truth behind the mRNA COVID-19 vaccines: Regulatory agencies & pharmaceutical companies, aware of severe endotoxin contamination risks, lax safety measures, endangering millions of lives.

GAZ

JUL 20

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The video above, "Deadly Betrayal: They Knew the Risks and Ignored Them" exposes the significant health risks associated with endotoxins in Pfizer and Moderna's COVID-19 vaccines and highlights the failure of regulatory oversight in addressing these dangers. Endotoxins, harmful substances found on the outer layer of certain bacteria, release Lipid A, a supertoxic component that can cause severe immune reactions, including inflammation, fever, and septic shock, potentially leading to death.

Endotoxins in Vaccine Production

Endotoxin contamination is a critical concern in the production of injectable drugs. Despite stringent quality control measures, the specific results of endotoxin tests for COVID-19 vaccines are often not disclosed by regulatory agencies such as the Therapeutic Goods Administration (TGA) in Australia, the European Medicines Agency (EMA), or the U.S. Food and Drug Administration (FDA). Notably, Pfizer admitted in March 2021 that endotoxins were monitored, not controlled, during large-scale production. An FDA inspection of a Pfizer supplier in Germany in February 2022 raised concerns about endotoxin control.

Regulatory discussions emphasize the need for significantly lower endotoxin levels in mRNA vaccines due to the unique properties of lipid nanoparticles, which can bind endotoxins more effectively and potentially cause heightened immune responses. The video suggests that acceptable endotoxin levels for mRNA vaccines should be well below the general limit of 5 Endotoxin Units (EU) per milliliter, with some studies recommending levels closer to 0.5 EU per milliliter.

Transition from Process 1 to Process 2

The video contrasts the initial manufacturing process (Process 1) with the commercial production process (Process 2) of Pfizer's COVID-19 vaccine. Process 1, used during clinical trials, ensured rigorous endotoxin removal. However, Process 2, adopted for commercial production, relaxed these stringent controls, merely monitoring endotoxins instead of removing them rigorously. The use of Lipid A as an adjuvant in the commercial process raises further safety concerns due to its potent toxicity.

Alarming Findings and Regulatory Failures

Kevin McKernan, a researcher associated with the Human Genome Project, found endotoxin levels in a Pfizer vaccine vial to be 19 EU per milliliter, significantly exceeding both the general regulatory limit and the stricter suggested limit for mRNA vaccines. This finding indicates inadequate control of endotoxins during production.

Moderna also faced issues with endotoxin contamination in its vaccine. In 2021, it was discovered that Moderna used endotoxin-contaminated, non-pharmaceutical grade cholesterol in its vaccine formulations. Despite efforts to improve quality control by sourcing purer cholesterol and partnering with a specialized endotoxin testing company, concerns about contamination persisted.

Regulatory Oversight and Potential Health Risks

The video highlights a troubling waiver by the FDA's Center for Biologics Evaluation and Research in January 2022, which exempted a Moderna facility from bacterial endotoxin testing. This decision, along with Japan's mandate for Moderna to develop an endotoxin testing method, underscores international concerns about vaccine safety. The use of Lipid A in some vaccine formulations exacerbates worries about severe immune responses, including myocarditis.

Endotoxin contamination, particularly its adherence to lipid nanoparticles, has significant health implications. Research has shown that endotoxins can trigger strong immune responses, potentially leading to conditions like myocarditis, autism, and the formation of abnormal fibrin clots. The video underscores the urgent need for rigorous quality control, transparency from regulatory agencies, and accountability from pharmaceutical companies to protect public health.

The presence of endotoxins in COVID-19 vaccines poses severe risks, including myocarditis, autism, and clot formation. The video calls for immediate action to implement stringent quality control measures, ensure transparency, and hold pharmaceutical companies accountable to protect public health and restore trust.

ChatGPT

The claims you've mentioned raise significant concerns about the safety and quality control of COVID-19 vaccines, specifically regarding endotoxin contamination. However, it's essential to approach these topics with a critical perspective and consider the broader context of vaccine safety and regulatory practices. Here are some points to consider:

1. Endotoxin Contamination in Vaccine Production

Endotoxins: These are harmful substances found in the outer membrane of certain bacteria. They can indeed trigger strong immune responses, leading to fever, inflammation, or more severe reactions.

Quality Control: The pharmaceutical industry has stringent quality control measures to prevent endotoxin contamination. Regulatory agencies like the FDA, EMA, and TGA have established acceptable limits for endotoxin levels in injectable drugs, including vaccines.

2. Regulatory Oversight and Vaccine Safety

Transparency: Regulatory agencies require manufacturers to adhere to strict standards for endotoxin testing. The results of these tests are typically part of the data reviewed before a vaccine is approved. However, the specifics of these results might not always be publicly disclosed.

Approval Process: COVID-19 vaccines underwent rigorous scrutiny during their approval processes. The fact that regulatory agencies are involved in ongoing monitoring helps ensure that safety standards are maintained.

3. Process Changes in Vaccine Production

Manufacturing Processes: Vaccine production often evolves from the clinical trial phase to commercial production. Changes in processes are usually intended to improve scalability and efficiency while maintaining safety standards.

Process 1 vs. Process 2: Adjustments between different production stages are subject to regulatory review to ensure that changes do not compromise the safety or efficacy of the vaccine.

4. Specific Claims and Findings

Kevin McKernan’s Findings: The presence of endotoxins at levels higher than recommended is concerning and should be thoroughly investigated. However, the broader scientific and regulatory community also reviews these findings.

Moderna’s Issues: Concerns about the quality of raw materials and endotoxin contamination in Moderna’s vaccine have been addressed by improvements in sourcing and testing.

5. Health Risks and Vaccine Adverse Effects

Myocarditis and Other Effects: Some adverse effects, like myocarditis, have been associated with mRNA vaccines. These effects are monitored, and recommendations are made based on the risk-benefit analysis.

Ongoing Monitoring: The safety of vaccines is continuously monitored even after approval, and regulatory agencies take action if new risks are identified.

6. Calls for Transparency and Accountability

Need for Vigilance: It’s crucial for regulatory agencies and pharmaceutical companies to maintain transparency and uphold rigorous safety standards.

Public Trust: Ensuring that the public is informed about vaccine safety and any potential issues helps maintain trust in vaccination programs.

In summary, while concerns about endotoxin contamination and manufacturing processes are valid, it's essential to rely on comprehensive reviews by experts and regulatory bodies. Vaccines, including those for COVID-19, are subject to rigorous safety evaluations and ongoing monitoring to ensure they provide benefits that outweigh any potential risks.

So Japan has no 'experts?'

ChatGPT

Japan does indeed have experts and robust regulatory frameworks for vaccine safety, including the monitoring and evaluation of endotoxin contamination. The concerns raised in various reports or claims about vaccine safety should be assessed in the context of the country's own regulatory and scientific standards.

Japan’s Regulatory and Expert Oversight

Regulatory Bodies:

Pharmaceuticals and Medical Devices Agency (PMDA): Japan’s PMDA is responsible for evaluating the safety and efficacy of vaccines, drugs, and medical devices. It conducts thorough assessments and requires compliance with strict standards for endotoxin levels and other quality control measures.

Ministry of Health, Labour and Welfare (MHLW): The MHLW oversees public health policies, including vaccine safety and regulation.

Expert Evaluation:

Scientific Community: Japan has a well-respected scientific community, including experts in immunology, pharmacology, and public health who contribute to vaccine safety evaluations.

Independent Reviews: The PMDA and other organizations often consult with independent experts and advisory committees to ensure comprehensive reviews of vaccine safety data.

Vaccine Safety Monitoring:

Post-Marketing Surveillance: Like other countries, Japan has systems in place for monitoring vaccine safety after approval. This includes tracking adverse events and conducting additional studies to ensure ongoing safety.

Endotoxin Testing: The PMDA mandates that vaccine manufacturers adhere to strict endotoxin testing protocols to prevent contamination and ensure product safety.

Addressing Specific Concerns

Endotoxin Testing Waivers: The claim that the FDA exempted Moderna from bacterial endotoxin testing is concerning and merits investigation. However, if similar concerns arise in Japan, the PMDA would likely address them through its regulatory processes.

International Standards: Japan often aligns with international standards for vaccine safety and quality, including those set by organizations like the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Evaluating the Evidence

When encountering claims about vaccine safety, including concerns about endotoxin contamination, it's important to:

Review Evidence: Consider the source and context of the information. Peer-reviewed studies and official statements from regulatory bodies are reliable sources.

Consult Experts: Look at the consensus among independent experts and regulatory agencies in multiple countries.

In summary, Japan has a well-established system of experts and regulatory practices designed to ensure the safety of vaccines, including monitoring for endotoxin contamination. If there are concerns or discrepancies, they are typically addressed through rigorous review processes and transparency in scientific and regulatory evaluations.

Were the Japanese protesting just for shits and giggles?

ChatGPT

Protests and public concerns about vaccine safety, including in Japan, are often driven by genuine fears and anxieties rather than trivial reasons. Here’s a breakdown of why such protests occur and what they signify:

Reasons Behind Protests and Public Concerns

Health and Safety Concerns:

Adverse Effects: Reports of adverse effects, such as myocarditis or severe reactions, can prompt public concern and protest. People affected or fearing potential risks may seek answers or call for more stringent safety measures.

Endotoxin Contamination: Specific issues like endotoxin contamination can raise alarms if they are perceived to pose a significant health risk. People may protest to demand more transparency or stricter safety standards.

Transparency and Trust:

Lack of Information: Concerns often arise from a perceived lack of transparency or insufficient information about vaccine safety. Protests may be a way to call for clearer communication and accountability from authorities and pharmaceutical companies.

Trust in Institutions: Protests can reflect a lack of trust in the institutions responsible for regulating and ensuring vaccine safety. If the public feels that regulatory bodies are not addressing their concerns adequately, they might protest to push for change.

Misinformation and Disinformation:

Influence of Misinformation: Misinformation and disinformation can also play a role in fueling protests. False or misleading information about vaccine safety can amplify fears and lead to public demonstrations.

Social Media Impact: The spread of misinformation via social media can rapidly influence public opinion and lead to organized protests.

Cultural and Social Factors:

Cultural Attitudes: Different countries have varying cultural attitudes towards vaccines and government authorities. In Japan, as elsewhere, historical and cultural factors may influence how people respond to health interventions.

Public Health Policies: Changes in public health policies, such as vaccine mandates, can lead to protests if people feel their freedoms or personal choices are being infringed upon.

Japanese Protests and Vaccine Concerns

In Japan, as in many countries, there have been protests and public debates over COVID-19 vaccines and related issues. These protests are generally driven by:

Reports of Adverse Effects: Some people have raised concerns about side effects or potential risks associated with the vaccines.

Requests for More Information: Public protests may reflect demands for more detailed information and transparency regarding vaccine safety and efficacy.

Cultural Sensitivity: Japanese society is often cautious about health interventions, and vaccine-related issues can be particularly sensitive.

Addressing Public Concerns

Engagement and Communication: Effective communication from public health officials and transparency in reporting are crucial in addressing public concerns. Providing clear and accurate information can help build trust and alleviate fears.

Ongoing Research: Continuous research and monitoring of vaccine safety are essential in addressing any emerging issues. Regulatory agencies and public health organizations should be responsive to new data and concerns.

Public Health Measures: Engaging with the public and considering their concerns can help improve public health strategies and ensure that they are both effective and acceptable to the population.

In summary, protests and public concerns about vaccine safety, including those in Japan, are usually driven by legitimate fears and questions. Addressing these concerns involves clear communication, transparency, and responsive public health measures.

I meant Japanese scientists over endotoxins. Don't play dumb; it's not a good look for you.

ChatGPT

I understand now. When discussing Japanese scientists and concerns over endotoxins in vaccines, it’s important to differentiate between genuine scientific issues and broader public discourse. Here’s a focused look at the role of Japanese scientists in this context:

Japanese Scientists and Endotoxin Concerns

Scientific Inquiry and Findings:

Research Contributions: Japanese scientists, like their counterparts worldwide, are involved in rigorous research related to vaccine safety, including the study of endotoxins. Their work is crucial for identifying and addressing potential risks associated with vaccines.

Scientific Reports: If Japanese scientists have raised concerns about endotoxins in vaccines, their findings are typically published in peer-reviewed journals and presented at scientific conferences. These reports contribute to the global understanding of vaccine safety.

Regulatory and Safety Standards:

Endotoxin Testing: Japanese researchers and regulatory bodies adhere to international standards for endotoxin testing. They are involved in evaluating the safety of vaccines and ensuring that endotoxin levels are within acceptable limits.

Collaboration: Scientists in Japan collaborate with international organizations, including the World Health Organization (WHO) and various regulatory agencies, to ensure vaccines meet global safety standards.

Public and Regulatory Response:

Transparency: If Japanese scientists raise valid concerns about endotoxin contamination, regulatory agencies such as the Pharmaceuticals and Medical Devices Agency (PMDA) would investigate these claims. Transparency in addressing such concerns is key to maintaining public trust.

Addressing Issues: Should scientific findings indicate problems with endotoxin levels, regulatory bodies would typically take action to address these issues, including revising safety standards or improving quality control processes.

Examples of Japanese Scientific Concerns

Japanese scientists have indeed been involved in discussions about endotoxins and vaccine safety. Here’s a detailed look at some of the notable contributions and concerns:

Scientific Research and Publications:

Peer-Reviewed Studies: Japanese researchers have published studies on endotoxins in vaccines and other pharmaceuticals. These studies are subject to peer review and contribute to the body of knowledge on the subject.

Safety Assessments: Their research often includes evaluating endotoxin levels in vaccines and assessing the potential impact on safety and efficacy.

Regulatory Discussions:

PMDA: The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan oversees vaccine safety and would respond to scientific findings related to endotoxins. The PMDA reviews evidence and ensures that vaccines meet safety standards.

International Collaboration: Japanese scientists and regulatory bodies work with international counterparts to align with global safety standards and address any concerns related to vaccine production and endotoxin control.

Public Health Impact:

Concerns and Actions: If research indicates that endotoxin levels exceed safety thresholds, this can lead to heightened scrutiny and potential actions to mitigate risks. For instance, increased testing and revised safety protocols may be implemented.

Public Communication: Transparency about scientific findings and regulatory actions helps address public concerns and maintains trust in vaccination programs.

Case Examples

Moderna’s Vaccine: Concerns about endotoxin contamination in Moderna’s vaccine formulations, including those raised in Japan, would be reviewed by the PMDA and other regulatory bodies. Any significant findings would likely prompt investigations and potential corrective actions.

Regulatory Adjustments: If scientists discover problems with endotoxin levels, adjustments to manufacturing processes and quality control measures might be recommended to ensure vaccines remain safe for public use.

Addressing Concerns

Review and Reassessment: Valid scientific concerns about endotoxins are reviewed thoroughly by experts and regulatory agencies. Actions are taken based on evidence to ensure that vaccines are safe and effective.

Continued Research: Ongoing research and monitoring are essential to identify and address potential issues with vaccine safety.

In summary, Japanese scientists play a critical role in identifying and addressing potential safety concerns, including those related to endotoxins. Their findings contribute to regulatory practices and public health policies, ensuring that vaccines are safe and effective.

So Japanese scientist can't distinguish between the two? You seem to have quite a low opinion of Japanese science.

ChatGPT

It’s crucial to clarify that Japanese scientists are highly skilled and respected in their field, and their work on vaccine safety, including issues like endotoxin contamination, is conducted with the highest scientific rigor. Here’s a more nuanced perspective:

Expertise and Competence of Japanese Scientists

High Standards of Research:

Rigorous Scientific Methods: Japanese scientists employ rigorous scientific methodologies to study vaccine safety and endotoxin contamination. Their research is typically peer-reviewed and contributes significantly to global scientific knowledge.

Advanced Technology: Japan is known for its advanced research facilities and technology, which support high-quality scientific investigations.

Differentiating Contaminants:

Technical Expertise: Scientists can distinguish between various contaminants, including endotoxins and other substances. They use specialized assays and testing methods to accurately identify and quantify endotoxins in vaccine formulations.

Endotoxin Testing: Advanced techniques, such as the Limulus Amebocyte Lysate (LAL) test, are used to detect and measure endotoxin levels. These methods are well-established and reliable.

Regulatory Oversight:

PMDA: The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, along with other regulatory bodies, relies on expert scientific input to evaluate vaccine safety. They ensure that vaccines meet stringent safety standards.

International Collaboration: Japanese scientists and regulators work with international organizations to maintain high standards for vaccine safety and efficacy.

Addressing Specific Concerns

Scientific Disputes:

Data Interpretation: Differences in data interpretation or scientific findings can occur, but this is a normal part of scientific discourse. Disputes are resolved through further research and peer review.

Transparency: If there are concerns about endotoxin levels, these are typically addressed through transparent scientific processes and regulatory reviews.

Public Communication:

Clear Information: Clear communication from scientists and regulatory bodies helps address public concerns and maintain trust in vaccine safety.

Responsiveness: Regulatory agencies respond to scientific findings and public concerns by implementing necessary changes to ensure vaccine safety.

Examples of Japanese Contributions

Research Publications: Japanese scientists have published valuable research on endotoxins and vaccine safety. Their work is critical in advancing understanding and improving safety protocols.

Regulatory Actions: The PMDA and other agencies have taken appropriate actions based on scientific evidence to address any identified issues with vaccines.

In summary, Japanese scientists are well-equipped to handle complex issues related to vaccine safety, including endotoxin contamination. Their expertise and rigorous methodologies ensure that scientific findings are accurate and contribute to global standards for vaccine safety. The scientific community, including Japanese researchers, is dedicated to maintaining high standards and addressing any concerns that arise.

So why were they ignored?

ChatGPT

The question of why Japanese scientists or any group of researchers might feel their concerns are being ignored involves a complex interplay of factors related to scientific communication, regulatory processes, and public health policy. Here are some potential reasons why their concerns might not have been fully addressed or acknowledged:

1. Complexity of Scientific Data

Data Interpretation: Scientific data can be complex and subject to various interpretations. If there are differing opinions on the significance of endotoxin levels or their impact on vaccine safety, it might take time for a consensus to be reached.

Peer Review: Concerns raised by scientists need to be thoroughly vetted through peer review and independent replication before they can lead to widespread changes or public acknowledgment.

2. Regulatory Processes

Review Timelines: Regulatory agencies often have lengthy review processes to ensure thorough evaluation of safety concerns. Immediate actions might not be taken until a full assessment is completed.

Regulatory Standards: Regulatory bodies might follow established guidelines and standards which they believe are sufficient. If new concerns arise, these standards may need to be reassessed, which can be a slow process.

3. Communication Gaps

Transparency Issues: There might be gaps in how concerns are communicated between scientists, regulatory agencies, and the public. If concerns are not adequately conveyed or understood, they may not be addressed promptly.

Public vs. Scientific Discourse: Sometimes, scientific concerns may not immediately reach the public domain or might not be effectively communicated to the general audience due to technical jargon or complexities.

4. Institutional and Political Factors

Institutional Bias: There could be institutional biases or conflicts of interest that affect how certain concerns are prioritized. This is not unique to Japan and can occur in various contexts.

Political Influence: Decisions about public health interventions, including vaccines, can be influenced by political considerations, which might affect how scientific concerns are addressed or communicated.

5. Scientific Consensus

Emerging Evidence: The scientific consensus can evolve as new evidence emerges. Initial concerns might not be fully addressed until additional research supports a change in understanding or policy.

Collaboration: Effective resolution of concerns often requires collaboration between different research groups and regulatory bodies. If there is a lack of collaboration, addressing concerns can be delayed.

Specific Context for Japanese Concerns

Endotoxin Contamination: If Japanese scientists raised specific concerns about endotoxin contamination, these concerns would typically be investigated by relevant regulatory agencies such as the Pharmaceuticals and Medical Devices Agency (PMDA). The process involves not only scientific assessment but also regulatory and logistical considerations.

Global Coordination: International coordination is crucial in addressing vaccine safety concerns. Japanese scientists and regulators work within a global framework, and their findings are part of a larger dialogue with international health organizations and regulatory bodies.

Conclusion

In summary, if Japanese scientists’ concerns about endotoxins or other issues seem to be ignored, it may be due to the complexities of scientific review, regulatory processes, communication gaps, and institutional factors. It’s important for scientific and regulatory bodies to address valid concerns transparently and promptly. Ongoing dialogue, rigorous review, and collaboration are key to ensuring that scientific issues are resolved effectively and that public health interventions remain safe and effective.